| CTRI Number |
CTRI/2022/01/039420 [Registered on: 14/01/2022] Trial Registered Prospectively |
| Last Modified On: |
24/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Assessment of Dietary Risk Factors and Evaluation of Impact of Nutrition Education Intervention Among young
Heart patients. |
|
Scientific Title of Study
|
Assessment and Evaluation of Dietary Risk Factors and Impact of Nutrition Education Intervention Among Premature
Coronary Artery Disease Individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIDYAVATI HG |
| Designation |
Senior Dietician, Research Scholar |
| Affiliation |
Sri Jayadeva Institute of Cardiovascular Sciences and research |
| Address |
Department of Nutrition, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bannerghatta Road, Jayanagar 9th Block-Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
9845675260 |
| Fax |
|
| Email |
vidya.shashi202@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Sridhar |
| Designation |
Professor of Cardiology, Unit Head |
| Affiliation |
Sri Jayadeva Institute of Cardiovascular Sciences and Research Bangalore |
| Address |
Department Of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences and research, Bannerghatta Road Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
9845488313 |
| Fax |
|
| Email |
srisrisastry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Reddy |
| Designation |
Professor & Head, Department of Clinical Nutrition &Dietetics |
| Affiliation |
Sri Devaraj Urs Academy for Higher Education and Research |
| Address |
Professor and Head
Department of Clinical Nutrition and Dietetics
Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar
Bangalore
KARNATAKA
563103
India |
| Phone |
9972307909 |
| Fax |
|
| Email |
drmmadhavireddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayadeva Institute of Cardiovascular Sciences and Research ,Jayanagar 9th Block, Bannerghatta Road, Bangalore 560069 |
|
|
Primary Sponsor
|
| Name |
Sri Jayadeva Institute of Cardiovascular Sciences and Research |
| Address |
Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bannerghatta Road, Jayanagar 9th Block-Bangalore |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| VIDYAVATI HG |
Sri Jayadeva Institute of Cardiovascular Sciences and Research |
Department of Nutrition, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bannerghatta Road, Jayanagar 9th Block-Bangalore
Bangalore
KARNATAKA |
9845675260
vidya.shashi202@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,JAYADEVA INSTITUTE OF CARDIOVASCULAR SCIENCES AND RESEARCH ,BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I222||Subsequent non-ST elevation (NSTEMI) myocardial infarction, (2) ICD-10 Condition: I22||Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction, (3) ICD-10 Condition: I22||Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nutrition Education Intervention |
For Intervention, Individual approach will be followed. In individual approach, participants will be given nutrition education by the investigator by face to face counselling for dietary modifications in their daily life on their admission to hospital before discharge, again during 1 Month,3 Months follow up visits. Information booklet on Nutrition approach in PCAD will be given to and patient will be followed up till 6 months.
Blood parameters ,Anthropometric measurements, Data on dietary habits are collected at 0,1,3,6 Months.
|
| Comparator Agent |
Standard Hospital treatment protocol will be followed |
standard hospital treatment protocol followed including diet counselling but Nutrition Education Intervention not given and follow up calls not done for the comparator or control group but blood lipid parameters, anthropometric measurements and data on dietary habits are collected dat 0,1,3,6 Months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients with diagnosis of ischemic heart disease, as evidenced by
a) Documented Acute Coronary Syndrome (Unstable angina, ST elevation/Non-ST Elevation myocardial Infraction)
b)Chronic stable angina with evidence of coronary artery disease
2.Patients willing for Clinical follow up in the same institution.
|
|
| ExclusionCriteria |
| Details |
•Patients having a history of chronic alcoholism, concomitant liver or kidney disease and acute or chronic infection
•Patients taking hypolipidemic drugs, oral contraceptives or hormone replacement Therapy
•Patients with Clinical heart failure, LV dysfunction (EF<45)
•Patients with mechanical complications of MI during Hospital admission.
•Patients on treatment for Comorbidities like Diabetes, Hypertension, Cholesterol
•Patients unwilling to give informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Nutrition education as a secondary prevention measure will help to prevent the evolution of the disease towards multi-vessel disease, repeated coronary events & improve the quality of life.
|
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes are expected in dietary eating habit, blood lipid parameters, anthropometric measurements |
at 3 Months and 6 Months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vidya.shashi202@gmail.com].
- For how long will this data be available start date provided 30-12-2024 and end date provided 30-12-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The aim of this study is to Assess the impact of nutrition education to reduce the dietary risk factors and to improve the metabolic cardio-vascular risk factors in PCAD individuals.
The objectives of the study are
- To assess the nutritional status and identify diet related risk factors in individuals with PCAD.
- To co-relate the changes in nutrition status of PCAD individuals with the knowledge acquired by nutrition education.
- To evaluate the impact of nutrition education intervention on risk reduction of PCAD.
Probable outcomes of the study- The intervention will translate the best-available dietary evidence into a manual/ booklet for participants and guiding tool for Accredited Practicing Dietitian/ Registered Dietician (APD/RD) to be implemented in cardiac rehabilitation facilities.
- Nontraditional risk factors like Chronic inflammation, Homocysteine, can be addressed through traditional modifiable dietary risk factors.
- Nutrition education as a secondary prevention measure will help to prevent the evolution of the disease towards multi-vessel disease, repeated coronary events & improve the quality of life.
|